Prefrontal Transcranial Random Noise Stimulation in Patients With Depression

NCT ID: NCT02207582

Last Updated: 2018-06-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-12-06

Brief Summary

Transcranial random noise stimulation is used to stimulate the prefrontal cortices in patients with depression. It's a placebo-controlled two-arm study.

Detailed Description

Transcranial random noise stimulation (tRNS) is a non-invasive electric stimulation technique of the brain which was shown to be superior effective in contrast to other electric stimulation such as transcranial direct current stimulation (tDCS). These studies investigated mainly healthy controls and specific tasks. Only one case report is available for depression. Here we stimulate patients with depression with tRNS in a placebo-controlled two-arm design. Stimulation will be done as add-on to standard therapy. Electrodes will be applied over both dorsolateral prefrontal cortices which are standard target points of tDCS and also transcranial magnetic stimulation in depression.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Verum Prefrontal tRNS

2mA of tRNS (DC-Stimulator, NeuroConn GmbH, Germany) with a zero offset will be applied to the left and right dorsolateral prefrontal cortex. Treatment will consist of 15 days with 20 minutes stimulation per day. Voltage will be ramped at the begin and end of a stimulation for 10 seconds.

Group Type: EXPERIMENTAL

Verum Prefrontal tRNS

Intervention Type: DEVICE

2mA of tRNS (DC-Stimulator, NeuroConn GmbH, Germany) with a zero offset will be applied to the left and right dorsolateral prefrontal cortex. Treatment will consist of 15 days with 20 minutes stimulation per day. Voltage will be ramped at the begin and end of a stimulation for 10 seconds.

Placebo Prefrontal tRNS

2mA of tRNS (DC-Stimulator, NeuroConn GmbH, Germany) with a zero offset will be applied to the left and right dorsolateral prefrontal cortex. Treatment will consist of 15 days with 20 minutes stimulation per day. Voltage will be ramped at the begin and end of a stimulation for 10 seconds. Placebo stimulation will consist of just applying the ramps at the begin and end of the stimulation.

Group Type: PLACEBO_COMPARATOR

Placebo Prefrontal tRNS

Intervention Type: DEVICE

2mA of tRNS (DC-Stimulator, NeuroConn GmbH, Germany) with a zero offset will be applied to the left and right dorsolateral prefrontal cortex. Treatment will consist of 15 days with 20 minutes stimulation per day. Voltage will be ramped at the begin and end of a stimulation for 10 seconds. Placebo stimulation will consist of just applying the ramps at the begin and end of the stimulation.

Interventions

Verum Prefrontal tRNS

2mA of tRNS (DC-Stimulator, NeuroConn GmbH, Germany) with a zero offset will be applied to the left and right dorsolateral prefrontal cortex. Treatment will consist of 15 days with 20 minutes stimulation per day. Voltage will be ramped at the begin and end of a stimulation for 10 seconds.

Intervention Type: DEVICE

Placebo Prefrontal tRNS

2mA of tRNS (DC-Stimulator, NeuroConn GmbH, Germany) with a zero offset will be applied to the left and right dorsolateral prefrontal cortex. Treatment will consist of 15 days with 20 minutes stimulation per day. Voltage will be ramped at the begin and end of a stimulation for 10 seconds. Placebo stimulation will consist of just applying the ramps at the begin and end of the stimulation.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• episode of depression (unipolar or bipolar) ( ICD-10)
• female or male between 18 and 70 years old
• skills to participate in all study procedures
• 18 or more points in the Hamilton rating scale or depression
• written informed consent

Exclusion Criteria

• clinically relevant unstable internal or neurological comorbidity
• evidence of significant brain malformations or neoplasm, head injury
• cerebral vascular events
• neurodegenerative disorders affecting the brain or prior brain surgery
• metal objects in and around body that can not be removed
• pregnancy
• alcohol or drug abuse
• eczema on the head
• heart pacemaker
• high dose tranquillizers

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Regensburg

OTHER

Sponsor Role: lead

Responsible Party

Berthold Langguth, MD, Ph.D.

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Berthold Langguth

Role: PRINCIPAL_INVESTIGATOR

University of Regensburg

Locations

University of Regensburg

Regensburg, , Germany

Countries

Germany

Other Identifiers

tRNS in depression

Identifier Type: -

Identifier Source: org_study_id